Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Gingiva
研究概览
简要总结
The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
- •Good oral hygiene
- •Patient aging 20-40 y
- •Patients with proximal deep carious lesion
- •International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
- •Normal response to a vitality test.
排除标准
- •poor general health
- •poor oral hygiene
- •Teeth would need direct pulp capping
- •Teeth act as abutment for fixed or removable prosthesis.
- •patients with excessive parafunctional habits
- •Patient potentially unable to be compliant to recall visits
研究组 & 干预措施
Highly viscous Glass Ionomer
Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
干预措施: Highly viscous glass ionomer (cervical margin relocation) (Procedure)
Low shrinkage Flowable Composite
Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
干预措施: Low shrinkage Flowable Composite (cervical margin relocation) (Procedure)
Resin Modified Glass Ionomer
Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
干预措施: Resin Modified Glass Ionomer (cervical margin relocation) (Procedure)
Bioactive Ionic Resin
Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
干预措施: Bioactive Ionic Resin (cervical margin relocation) (Procedure)
结局指标
主要结局
Gingiva
时间窗: three year follow up
Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva
Modified World Dental Federation (FDI) clinical Criteria
时间窗: three year follow up
1. Functional Properties of restorations: 1. Fracture of material and retention 2. Marginal adaptation 3. Radiographic examination 2. Biological Properties of restorations 1. Postoperative (hyper-sensitivity and tooth vitality 2. Recurrence of caries 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal Response 5. Adjacent mucosa Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor. Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated
次要结局
未报告次要终点